NORTH CHICAGO, Ill.,
Aug. 29, 2019 /PRNewswire/
-- AbbVie (NYSE: ABBV), a research based global
biopharmaceutical company, today announced that MERU, a Phase
3 trial evaluating Rova-T as a first-line maintenance therapy for
advanced small-cell lung cancer (SCLC), demonstrated no survival
benefit at a pre-planned interim analysis for patients receiving
Rova-T as compared with placebo. The overall safety profile was
generally consistent with that observed in previous studies. The
MERU trial is being closed, and the Rova-T research and development
program has been terminated. AbbVie will move forward prioritizing
other development programs within its oncology pipeline.
An Independent Data Monitoring Committee (IDMC) recommended
terminating MERU due to lack of survival benefit for patients
receiving Rova-T compared with the placebo control arm based on
results at a pre-planned interim analysis. Results from the MERU
trial will be presented at a future medical meeting and/or
published in a peer-reviewed medical journal.
"Small-cell lung cancer continues to be one of the most
difficult-to-treat cancers where there is a significant need for
transformative therapies. We are disappointed with this outcome for
the patients who suffer from this disease," said Margaret Foley, M.D., vice president, global
head of solid tumor development, AbbVie. "We remain committed to
researching and developing other therapies with the potential to
transform care for patients with small-cell lung cancer and other
malignancies."
Moving forward, AbbVie will continue to focus research and
development efforts on other therapies in its oncology portfolio of
investigational and marketed medicines. AbbVie's oncology portfolio
currently consists of marketed medicines and investigational
medicines being evaluated worldwide in more than 300 clinical
trials and in more than 20 different tumor types.
About the Phase 3 MERU Trial
MERU is a Phase 3,
randomized, double-blind, placebo-controlled trial designed to
evaluate the efficacy of rovalpituzumab tesirine (Rova-T) as
maintenance therapy following first-line, platinum-based
chemotherapy in small-cell lung cancer (SCLC).
About Rovalpituzumab Tesirine
(Rova-T)
Rova-T is an investigational
antibody-drug conjugate targeting the cancer-stem cell-associated
delta-like protein 3 (DLL3)[1], which is expressed in more than 80
percent of small-cell lung cancer (SCLC) patient tumors, where it
is prevalent on tumor cells, including cancer stem cells, but not
present in healthy tissue.[2] Rova-T combines a targeted antibody
with a cytotoxic agent that is delivered directly to the
DLL3-expressing cancer cells.
Rova-T is not approved, and its efficacy and safety have not
been evaluated by health authorities.
About AbbVie in Oncology
At AbbVie, we strive to
discover and develop medicines that deliver transformational
improvements in cancer treatment by uniquely combining our deep
knowledge in core areas of biology with cutting-edge technologies,
and by working together with our partners – scientists, clinical
experts, industry peers, advocates, and patients. We remain focused
on delivering these transformative advances in treatment across
some of the most debilitating and widespread cancers. We are also
committed to exploring solutions to help patients obtain access to
our cancer medicines. AbbVie's oncology portfolio now consists of
marketed medicines and a pipeline containing multiple new molecules
being evaluated worldwide in more than 300 clinical trials and more
than 20 different tumor types. For more information, please visit
http://www.abbvie.com/oncology.
About AbbVie
AbbVie is a global, research and
development-based biopharmaceutical company committed to developing
innovative advanced therapies for some of the world's most complex
and critical conditions. The company's mission is to use its
expertise, dedicated people and unique approach to innovation to
markedly improve treatments across four primary therapeutic areas:
immunology, oncology, virology and neuroscience. In more than
75 countries, AbbVie employees are working every day to advance
health solutions for people around the world. For more information
about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, LinkedIn or Instagram.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, challenges to
intellectual property, competition from other products,
difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry. Additional information
about the economic, competitive, governmental, technological and
other factors that may affect AbbVie's operations is set forth in
Item 1A, "Risk Factors," of AbbVie's 2018 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
1 Saunders L. R. et al. A DLL3-targeted
antibody-drug conjugate eradicates high-grade pulmonary
neuroendocrine tumor-initiating cells in vivo. Sci. Transl. Med.
2015;7(302): 1-13.
2 ClinicalTrials.gov (2016). Study of
Rovalpituzumab Tesirine (SC16LD6.5) for Third-line and Later
Treatment of Subjects With Relapsed or Refractory Delta-Like
Protein 3-Expressing Small-Cell Lung Cancer (TRINITY).
Accessed March 21,
2018. https://clinicaltrials.gov/ct2/show/NCT02674568?term=SC16LD6.5&rank=2.
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SOURCE AbbVie